Takeda’s dengue fever vaccine Qdenga has demonstrated its long-term benefits against infection and hospitalisation in a Phase III trial.
During the TIDES study (NCT02747927), two doses of the live, attenuated vaccine prevented virologically confirmed dengue (VCD) in 61.2% of participants 4.5 years after dosing.
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The vaccine’s benefits were observed against all four serotypes of the dengue virus across seven years.
Qdenga also reduced the prevalence of dengue-related hospitalisation, with 84.1% of individuals given the vaccine avoiding this outcome at the 4.5-year mark. Meanwhile, vaccine efficacy remained at 90.6% after the administration of a booster dose.
After the initial 4.5-year study period, patients randomised to the Qdenga arm were given a booster dose of the vaccine, which Takeda theorised would enhance and sustain the jab’s preventive activity.
While a booster dose at the 4.5-year mark did enhance Qdenga’s effectiveness, this impact was only marginal, as the vaccine demonstrated a vaccine effectiveness of 74.3% after two years following booster jab administration.
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By GlobalDataIn the latter portion of the TIDES study, there were no new safety signals associated with booster jab administration.
Dengue’s prevalence on the up
The positive results of the seven-year study come amid a sharp rise in the prevalence of dengue fever worldwide, with more than 14 million cases and 9,508 deaths reported in 2024 alone.
Dengue is also associated with poorer neonatal outcomes when contracted by pregnant women, as it can increase the risk of preterm birth, congenital abnormalities and low birth weight. This impact is seen primarily during maternal infection in the third trimester.
According to Edson Moreira, senior researcher at the Brazilian Ministry of Health’s Oswaldo Cruz Foundation, the surge in dengue cases is primarily driven by both “inadequate urbanisation” and climate change.
Moreira also noted that the infectious disease, which is characterised by flu-like symptoms, is particularly prevalent in Brazil. In 2024, the country accounted for just under 50% of all reported dengue cases in the Americas.
As dengue has presented a significant issue to global healthcare systems – especially in the Southern hemisphere – Moreira believes that there is an “urgent need for dengue prevention methods”.
Currently approved in 41 countries, Qdenga has also earned a place on the World Health Organization’s (WHO) list of prequalified vaccines in May 2024.
Dengue vaccines hard to access in the US
Despite its widespread market penetration, following its first approval in 2022 in Indonesia, Qdenga is yet to debut on the US market. This followed Takeda’s decision to withdraw its application to the US Food and Drug Administration (FDA) for the vaccine in 2023 after regulators raised issues with the TIDES study’s data collection process.
There has also been a muted success of Sanofi’s Dengvaxia (dengue tetravalent vaccine) on the US market, which became the first preventative measure for dengue to secure approval from the FDA in 2019, which could make the US an unattractive market for Takeda to explore, despite its new data.
Though it is the only dengue vaccine to date to obtain the FDA approval, Sanofi will discontinue the drug by Q3 2026, due to “a lack of demand on the global market”.
While Sanofi may not have seen significant commercial success with Dengvaxia, analysts at GlobalData forecast that Takeda’s Qdenga will earn blockbuster status in 2031, pulling in $1bn in global sales during the year.
GlobalData is the parent company of Clinical Trials Arena.
